German Commission E Monographs (Phytotherapy) – Introduction

List of 384 German Commission E Monographs (Phytotherapy) at Heilpflanzen-Welt.de

In 1978, the Ger­man govern­ment estab­lished an expert com­mit­tee, the Com­mis­si­on E, to eva­lua­te the safe­ty and effi­ca­cy of over 300 herbs and herb com­bi­na­ti­ons sold in Germany.

The German Legal and Regulatory Enviornment and the History and Background of Commission E

Legal History

In con­trast to other count­ries in Euro­pe, her­bal medi­ci­nes have a spe­cial sta­tus in Ger­ma­ny, begin­ning with the Impe­ri­al Decree of 1901 that per­mit­ted the trade of many bota­ni­cal drugs out­side phar­maci­es. This was incor­po­ra­ted into Artic­les 29 – 31 of the First Medi­ci­nes Act (AMG) of 1961 (Schil­cher, 1998b).

The legal basis for modern drug laws in Ger­ma­ny is based on Euro­pean Com­mu­ni­ty Direc­ti­ves 65/​65/​EEC issued in 1965, plus Direc­ti­ves 75/​318/​EEC and 75/​319/​EEC, issued in 1975. Under the terms of the­se direc­ti­ves all mem­ber sta­tes of the Euro­pean Com­mu­ni­ty pled­ged to estab­lish a for­mal review of all medi­cinal pro­ducts on the mar­ket at that time and to assu­re that they met appro­pria­te stan­dards for qua­li­ty and puri­ty. Pro­ducts were to be review­ed for safe­ty and effi­ca­cy and re-regis­tered by 1990 in Germany.

Con­se­quent­ly, on August 24, 1976, Ger­ma­ny pas­sed the Second Medi­ci­nes Act (Arz­nei­mit­tel­ge­setz 1976, or AMG 76), which went into effect Janu­ary 1, 1978, and requi­red that the enti­re ran­ge of medi­ci­nes in the phar­maceu­ti­cal mar­ket (inclu­ding con­ven­tio­nal drugs, as well as medi­cinal plants and phy­to­me­di­ci­nes) be review­ed by sci­en­ti­fic com­mit­tees. AMG 76 includes spe­cial sec­tions on phy­to­me­di­ci­nes: Artic­le 22 Abs. 2 Nr.2, Sec­tion Artic­le 25 Abs., Artic­le 36, Artic­le 44, and Artic­le 45.

In 1978 the Minis­ter of Health estab­lished a series of com­mis­si­ons to review various cate­go­ries of drugs, inclu­ding an expert com­mit­tee for her­bal drugs and pre­pa­ra­ti­ons from medi­cinal plants, Com­mis­si­on E. The­se com­mis­si­ons were situa­ted at the Bun­des­ges-und­heits­amt (BGA), the Fede­ral Health Agen­cy, char­ged with revie­w­ing and appro­ving the safe­ty and effi­ca­cy of all drugs. In 1994 the BGA beca­me the Bun­des­in­sti­tut für Arz­nei­mit­tel und Medi­zin­pro­duk­te (BfArM), the Fede­ral Insti­tu­te for Drugs and Medi­cal Devices.

Accor­ding to the AMG 76, for pre­pa­ra­ti­ons that were alre­a­dy on the mar­ket at that time, a tran­si­ti­on peri­od of 12 years was allo­wed, fol­lo­wing Euro­pean gui­de­lines. During this time, the pro­ducts remain­ed on the mar­ket, but evi­dence of qua­li­ty, safe­ty, and effec­ti­ve­ness still requi­red vali­da­ti­on. The regu­la­ti­ons were desi­gned so that the manu­fac­tu­rer had to pro­vi­de pro­of of phar­maceu­ti­cal qua­li­ty for tra­di­tio­nal her­bal ingre­di­ents, whe­re­as eva­lua­tions of safe­ty and effec­ti­ve­ness were rele­ga­ted to the mono­graphs to be published by Com­mis­si­on E (Stein­hoff, 1997b).

Howe­ver, all drugs that came into the mar­ket after the law went into effect (1978) had to be eva­lua­ted accor­ding to the pro­ce­du­res for new drug appr­ovals. This appli­ed to her­bal and con­ven­tio­nal drugs ali­ke. The manu­fac­tu­rer must app­ly every five years for an exten­si­on of the drug regis­tra­ti­on. Pro­of of qua­li­ty, safe­ty, and effec­ti­ve­ness appli­ed equal­ly; howe­ver, for safe­ty and effec­ti­ve­ness, refe­rence to biblio­gra­phic evi­dence was allo­wed for her­bal drugs (Stein­hoff, 1997b).

The­se com­mis­si­ons sci­en­ti­fi­cal­ly eva­lua­ted the fol­lo­wing num­ber of medi­ci­nes: from 1978 until Sep­tem­ber 1994: 1,369 con­ven­tio­nal drugs, 360 her­bal drugs, and 187 vete­ri­na­ry drugs (Bus­se, 1997a). By the end of 1995, the total num­ber of herbs eva­lua­ted by Com­mis­si­on E was 360, whe­re­as the num­ber of herb parts review­ed as pre­pa­ra­ti­ons was at least 391. This see­ming dis­crepan­cy is becau­se in some cases the­re is a mono­graph for each of seve­ral parts from the same plant (e.g., Sen­na fruit and Sen­na leaf; Hawt­horn leaf with flower, Hawt­horn fruit, leaf, or flower respectively).

Composition of Commission E

Accor­ding to the Second Medi­ci­nes Act the mem­bers of the sci­en­ti­fic com­mit­tees must have expe­ri­ence in the respec­ti­ve the­ra­peu­tic area. Com­mis­si­on E was com­po­sed of 24 mem­bers pro­po­sed by asso­cia­ti­ons of the health pro­fes­sio­nals (phy­si­ci­ans, phar­macists, non-medi­cal prac­ti­tio­ners (Heil­prak­ti­ker), phar­ma­co­lo­gists, toxi­co­lo­gists, and bio­sta­tis­ti­ci­ans) and by repre­sen­ta­ti­ves of the phar­maceu­ti­cal indus­try (Kel­ler, 1992). Fif­ty per­cent are experts from the cli­ni­cal or the­ra­peu­tic field (Bus­se, 1996). Sci­en­tists and phy­si­ci­ans ser­ving on the Com­mis­si­on have aut­ho­red over 1,000 sci­en­ti­fic publi­ca­ti­ons, not only in phy­to­the­ra­py, but also in medi­ci­ne, phar­ma­co­lo­gy, den­ti­stry, health care deli­very, and medi­cal ethics. One long­stan­ding mem­ber has writ­ten that the inter­di­sci­pli­na­ry natu­re of the Com­mis­si­on is uni­que in the enti­re world (Schil­cher, 1997b). The Com­mis­si­on will be appoin­ted every three years by the Minis­ter of Health. The Com­mis­si­on is hea­ded by a Chair­man (Dr. Oel­ze) and a Vice Pre­si­dent (Prof. Dr. H. Schil­cher). The cont­act to the BfArM is Dr. K. Kel­ler, who is con­side­red the “Refe­ree” (Bericht­erstat­ter). For a list of the cur­rent mem­bers of the Com­mis­si­on, plea­se see page xvii.

Traditional Medicines

For old her­bal pro­ducts alre­a­dy on the mar­ket that could not meet Com­mis­si­on E stan­dards, a Tra­di­tio­nal Medi­ci­ne sta­tus was intro­du­ced in Janu­ary 1992 that per­mit­ted the re-regis­tra­ti­on of tra­di­tio­nal medi­ci­nes wit­hout requi­ring rigo­rous stu­dies and sci­en­ti­fic data on a spe­ci­fic pro­duct (Stein­hoff, 1993/​4b). Accor­ding to Artic­le 109a of the AMG 76, the­se tra­di­tio­nal pro­ducts must be safe and meet stan­dards for qua­li­ty. The chall­enge of pro­ving effi­ca­cy can be over­co­me by using tra­di­tio­nal use as a cri­ter­ion for effec­ti­ve­ness “drugs that have pro­ven useful for many years.” (Stein­hoff, 1997b.)

The­se “tra­di­tio­nal­ly used pre­pa­ra­ti­ons” also must pass the review and con­trol of the new Com­mis­si­on to 109a AMG 76, estab­lished in August 1996. This com­mis­si­on makes lists for tra­di­tio­nal medi­ci­nes (not limi­t­ed to herb-based pro­ducts) to include spe­ci­fic pro­ducts men­tio­ned in Artic­le 44(1) AMG 76. Medi­cinal claims must be limi­t­ed to minor con­di­ti­ons and pre­ven­ti­ve state­ments, and the phra­se “tra­di­tio­nal­ly used in” must be on the label. They can be inten­ded only for indi­ca­ti­ons such as streng­thening, invi­go­ra­ting, or sup­port­ing the body (pos­si­bly not unli­ke a struc­tu­re-func­tion cla­im under DSHEA in the U.S.), but they can­not be inten­ded to cure or tre­at a dise­a­se. Phy­to-medi­ci­nes appro­ved by this com­mis­si­on do not qua­li­fy for reim­bur­se­ment from medi­cal health plans (Shil­cher, 1998c). This com­mis­si­on is also com­po­sed of an inter­di­sci­pli­na­ry group of experts. Prof. H. Schil­cher is Vice Pre­si­dent of both this com­mis­si­on and Com­mis­si­on E (Schil­cher, 1997b).

In sum, alt­hough the­se pro­ducts must still meet stan­dards for qua­li­ty manu­fac­tu­re, their his­to­ri­cal uses are not docu­men­ted by plau­si­ble sci­en­ti­fic data. Thus, the­re is a distinc­tion bet­ween the stan­dards for the appr­oval of Tra­di­tio­nal Medi­ci­nes and the sci­en­ti­fic stan­dards for her­bal drugs appro­ved by Com­mis­si­on E (Bus­se, 1997; Stein­hoff, 1993/​4b, Schil­cher 1998).

Regar­ding the stan­dards for qua­li­ty, the phar­maceu­ti­cal qua­li­ty of Tra­di­tio­nal Medi­ci­nes must be docu­men­ted. As of the fall of 1997 the Com­mis­si­on to 109a AMG 76 has lis­ted over 800 sub­s­tances (many her­bal) that the manu­fac­tu­r­ers have peti­tio­ned for inclu­si­on. The BfArM does not inspect the manu­fac­tu­re of the­se medi­ci­nes, but the phar­maceu­ti­cal manu­fac­tu­rer must pro­vi­de a sta­tu­to­ry decla­ra­ti­on for the herb ingre­di­ent, dosa­ge form, and inten­ded use. (Stein­hoff, 1997b).

Members of Commission E

Distin­gu­is­hed phy­si­ci­ans and sci­en­tists ser­ving on the Com­mis­si­on include: